關於來氟米特(leflunomide, Arava®)安全性的最新資訊 Latest safety update on leflunomide(Arava®)

      基於服用來氟米特(leflunomide, Arava®)的病人可能出現嚴重肝損傷, 美國食物及藥物管理局(USFDA)要求在該藥的說明書中加入最新的警告性資訊, 以強調使用該藥出現嚴重肝損傷的風險。有關的警告性資訊包括:

  • 曾患有肝臟疾病的病人不應服用leflunomide。
  • 肝轉氨酶升高(ALT高於正常值上限的兩倍)的病人不應服用leflunomide。
  • 對於正在服用其他可引起肝損傷的藥物的病人, 應對其提高警覺。
  • 於開始leflunomide後三個月內應最少每個月監測一次肝轉氨酶, 其後應最少每三個月監測一次。
  • 如病人在服用leflunomide的過程中, ALT升高超出正常值上限的兩倍, 應停止使用leflunomide, 並服用cholestyramine以加速leflunomide從體內清除, 然後最少每星期檢查肝功能, 直至ALT值回到正常范圍。

     衛生專業人士應注意該藥出現嚴重肝損傷的風險, 確保該藥處方於合適的病人, 並且進行用藥監測。

                                                                                                                                                                          

    The United States Food and Drug Administration (USFDA) added information on severe liver injury to the Boxed Warning of leflunomide(Arava®) to highlight the risk of severe liver injury in patients using this drug. The information added to the Boxed Warning states:

  • Patients with pre-existing liver disease should not receive leflunomide.
  • Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive leflunomide.
  • Caution should be used in patients who are taking other drugs that can cause liver injury.
  • Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter.
  • If the ALT rises to greater than two times the upper limit of normal while the patient is on leflunomide – leflunomide should be stopped, cholestyramine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range.

    Healthcare professionals should be aware of the risk for severe liver injury with this drug, and ensure appropriate patient selection and monitoring.


Free Counter
Free Counter